Schedules of Controlled Substances: Temporary Placement of Furanyl Fentanyl Into Schedule I

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Notice of intent.

SUMMARY: The Administrator of the Drug Enforcement Administration is
issuing this notice of intent to temporarily schedule the synthetic
opioid, N-(1-phenethylpiperidin-4-yl)-N-phenylfuran-2-carboxamide
(furanyl fentanyl), into schedule I pursuant to the temporary
scheduling provisions of the Controlled Substances Act. This action is
based on a finding by the Administrator that the placement of this
synthetic opioid into schedule I of the Controlled Substances Act is
necessary to avoid an imminent hazard to the public safety. Any final
order will impose the administrative, civil, and criminal sanctions and
regulatory controls applicable to schedule I controlled substances
under the Controlled Substances Act on the manufacture, distribution,
possession, importation, exportation, research, and conduct of,
instructional activities of this synthetic opioid.

SUPPLEMENTARY INFORMATION: Any final order will be published in the
Federal Register and may not be effective prior to October 27, 2016.

Legal Authority

The Drug Enforcement Administration (DEA) implements and enforces
titles II and III of the Comprehensive Drug Abuse Prevention and
Control Act of 1970, as amended. 21 U.S.C. 801-971. Titles II and III
are referred to as the "Controlled Substances Act" and the
"Controlled Substances Import and Export Act," respectively, and are
collectively referred to as the "Controlled Substances Act" or the
"CSA" for the purpose of this action. The DEA publishes the
implementing regulations for these statutes in title 21 of the Code of
Federal Regulations (CFR), chapter II. The CSA and its implementing
regulations are designed to prevent, detect, and eliminate the
diversion of controlled substances and listed chemicals into the
illicit market while providing for the legitimate medical, scientific,
research, and industrial needs of the United States. Controlled
substances have the potential for abuse and dependence and are
controlled to protect the public health and safety.

Under the CSA, each controlled substance is classified into one of
five schedules based upon its potential for abuse, its currently
accepted medical use in treatment in the United States, and the degree
of dependence the drug or other substance may cause. 21 U.S.C. 812. The
initial schedules of controlled substances established by Congress are
found at 21 U.S.C. 812(c), and the current list of all scheduled
substances is published at 21 CFR part 1308.

Section 201 of the CSA, 21 U.S.C. 811, provides the Attorney
General with the authority to temporarily place a substance into
schedule I of the CSA for two years without regard to the requirements
of 21 U.S.C. 811(b) if she finds that such action is necessary to avoid
imminent hazard to the public safety. 21 U.S.C. 811(h)(1). In addition,
if proceedings to control a substance are initiated under 21 U.S.C.
811(a)(1), the Attorney General may extend the temporary scheduling for
up to one year. 21 U.S.C. 811(h)(2).

Where the necessary findings are made, a substance may be
temporarily scheduled if it is not listed in any other schedule under
section 202 of the CSA, 21 U.S.C. 812, or if there is no exemption or
approval in effect for the substance under section 505 of the Federal
Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 355. 21 U.S.C.
811(h)(1). The Attorney General has delegated scheduling authority
under 21 U.S.C. 811 to the Administrator of the DEA. 28 CFR 0.100.

Background

Section 201(h)(4) of the CSA, 21 U.S.C. 811(h)(4), requires the
Administrator to notify the Secretary of the Department of Health and
Human Services (HHS) of his intention to temporarily place a substance
into schedule I of the CSA.\1\ The

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Administrator transmitted notice of his intent to place furanyl
fentanyl in schedule I on a temporary basis to the Assistant Secretary
by letter dated June 22, 2016. The Assistant Secretary responded to
this notice by letter dated July 8, 2016, and advised that based on
review by the Food and Drug Administration (FDA), there are currently
no investigational new drug applications or approved new drug
applications for furanyl fentanyl. The Assistant Secretary also stated
that the HHS has no objection to the temporary placement of furanyl
fentanyl into schedule I of the CSA. Furanyl fentanyl is not currently
listed in any schedule under the CSA, and no exemptions or approvals
are in effect for furanyl fentanyl under section 505 of the FDCA, 21
U.S.C. 355. The DEA has found that the control of furanyl fentanyl in
schedule I on a temporary basis is necessary to avoid an imminent
hazard to public safety.

\1\ As discussed in a memorandum of understanding entered into
by the Food and Drug Administration (FDA) and the National Institute
on Drug Abuse (NIDA), the FDA acts as the lead agency within the HHS
in carrying out the Secretary's scheduling responsibilities under
the CSA, with the concurrence of NIDA. 50 FR 9518, Mar. 8, 1985. The
Secretary of the HHS has delegated to the Assistant Secretary for
Health of the HHS the authority to make domestic drug scheduling
recommendations. 58 FR 35460, July 1, 1993.

To find that placing a substance temporarily into schedule I of the
CSA is necessary to avoid an imminent hazard to the public safety, the
Administrator is required to consider three of the eight factors set
forth in section 201(c) of the CSA, 21 U.S.C. 811(c): The substance's
history and current pattern of abuse; the scope, duration and
significance of abuse; and what, if any, risk there is to the public
health. 21 U.S.C. 811(h)(3). Consideration of these factors includes
actual abuse, diversion from legitimate channels, and clandestine
importation, manufacture, or distribution. 21 U.S.C. 811(h)(3).

A substance meeting the statutory requirements for temporary
scheduling may only be placed in schedule I. 21 U.S.C. 811(h)(1).
Substances in schedule I are those that have a high potential for
abuse, no currently accepted medical use in treatment in the United
States, and a lack of accepted safety for use under medical
supervision. 21 U.S.C. 812(b)(1).

Furanyl Fentanyl

Furanyl fentanyl was first described in 1986 in the patent
literature. The scientific literature reported overdose events
involving furanyl fentanyl, among other fentanyl analogues in 2015 in
Sweden. No approved medical use has been identified for furanyl
fentanyl, nor has it been approved by the FDA for human consumption.
The recent identification of furanyl fentanyl in drug evidence and the
identification of this substance in association with fatal overdose
events indicate that this substance is being abused for its morphine-like properties.

Available data and information for furanyl fentanyl, summarized
below, indicate that this synthetic opioid has a high potential for
abuse, no currently accepted medical use in treatment in the United
States, and a lack of accepted safety for use under medical
supervision. The DEA's three-factor analysis is available in its
entirety under the public docket of this action as a supporting
document at www.regulations.gov under Docket Number DEA-448.

Factor 4. History and Current Pattern of Abuse

On October 1, 2014, the DEA implemented STARLiMS (a web-based,
commercial laboratory information management system) to replace the
System to Retrieve Information from Drug Evidence (STRIDE) as its
laboratory drug evidence data system of record. DEA laboratory data
submitted after September 30, 2014, are reposited in STARLiMS; data
from STRIDE and STARLiMS were queried on July 11, 2016. STARLiMS
registered 36 reports containing furanyl fentanyl, all reported in
2016, from California, Connecticut, Florida, Georgia, Maryland,
Montana, New Jersey, New York, North Carolina, North Dakota, Tennessee,
Utah, West Virginia, and the District of Columbia. The DEA is not aware
of any laboratory identifications of furanyl fentanyl prior to 2015.

The National Forensic Laboratory Information System (NFLIS) is a
national drug forensic laboratory reporting system that systematically
collects results from drug chemistry analyses conducted by other
federal, state and local forensic laboratories across the country.
According to NFLIS, the first report of furanyl fentanyl at other
federal, state, or local forensic laboratories was recorded in January
2016 in Ohio. From January through May 2016, a total of 80 submissions
involving furanyl fentanyl were reported in NFLIS as a result of law
enforcement encounters in Iowa, New Jersey, North Dakota, Ohio, and
Wisconsin (query date: July 11, 2016).

Evidence suggests that the pattern of abuse of fentanyl analogues,
including furanyl fentanyl, parallels that of heroin and prescription
opioid analgesics. Seizures of furanyl fentanyl have been encountered
in powder form. Furanyl fentanyl has also been encountered in drug
paraphernalia commonly associated with heroin or other opioid abuse
including glassine bags, and as a residue on spoons and bottle caps.
Furanyl fentanyl has been encountered as a single substance as well as
in combination with other substances of abuse, including heroin,
fentanyl, butyryl fentanyl, and U-47700. Furanyl fentanyl has caused
fatal overdoses, in which intravenous routes of administration are
documented.

Factor 5. Scope, Duration and Significance of Abuse

The DEA is currently aware of at least 128 confirmed fatalities
associated with furanyl fentanyl. The information on these deaths
occurring in 2015 and 2016 was collected from personal communications
or toxicology and medical examiner reports received by the DEA. These
deaths were reported from five states--Illinois (36), Maryland (41),
New Jersey (1), North Carolina (49), and Ohio (1). STARLiMS and NFLIS
have a total of 116 drug reports in which furanyl fentanyl was
identified in drug exhibits submitted to forensic laboratories in 2016
from law enforcement encounters in California, Connecticut, Florida,
Georgia, Iowa, Maryland, Montana, New Jersey, New York, North Carolina,
North Dakota, Ohio, Tennessee, Utah, West Virginia, Wisconsin, and the
District of Columbia. It is likely that the prevalence of furanyl
fentanyl in opioid analgesic-related emergency room admissions and
deaths is underreported as standard immunoassays may not differentiate
this substance from fentanyl.

The population likely to abuse furanyl fentanyl overlaps with the
population abusing prescription opioid analgesics and heroin. This is
evidenced by the routes of drug administration and drug use history
documented in furanyl fentanyl fatal overdose cases. Because abusers of
furanyl fentanyl are likely to obtain this substance through
unregulated sources, the identity, purity, and quantity are uncertain
and inconsistent, thus posing significant adverse health risks to the
end user. Individuals who initiate (i.e. use an illicit drug for the
first time) furanyl fentanyl abuse are likely to be at risk of
developing substance use disorder, overdose, and death similar to that
of other opioid analgesics (e.g., fentanyl, morphine, etc.).

Factor 6. What, if Any, Risk There Is to the Public Health

Furanyl fentanyl exhibits pharmacological profiles similar to that
of fentanyl and other [micro]-opioid receptor agonists. The toxic
effects of furanyl fentanyl in humans are demonstrated by overdose
fatalities involving this substance. Abusers of furanyl fentanyl may
not know the origin, identity, or purity of this substance, thus posing
significant adverse health risks when compared to abuse of
pharmaceutical

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preparations of opioid analgesics, such as morphine and oxycodone.

Based on the documented case reports of overdose fatalities, the
abuse of furanyl fentanyl leads to the same qualitative public health
risks as heroin, fentanyl and other opioid analgesic substances. The
public health risks attendant to the abuse of heroin and opioid
analgesics are well established and have resulted in large numbers of
drug treatment admissions, emergency department visits, and fatal
overdoses.

Furanyl fentanyl has been associated with numerous fatalities. At
least 128 confirmed overdose deaths involving furanyl fentanyl abuse
have been reported throughout Illinois (36), Maryland (41), New Jersey
(1), North Carolina (49), and Ohio (1) between 2015 and 2016.

Finding of Necessity of Schedule I Placement To Avoid Imminent Hazard
to Public Safety

In accordance with 21 U.S.C. 811(h)(3), based on the available data
and information, summarized above, the continued uncontrolled
manufacture, distribution, reverse distribution, importation,
exportation, conduct of research and chemical analysis, possession, and
abuse of furanyl fentanyl poses an imminent hazard to the public
safety. The DEA is not aware of any currently accepted medical uses for
furanyl fentanyl in the United States. A substance meeting the
statutory requirements for temporary scheduling, 21 U.S.C. 811(h)(1)
may only be placed in schedule I. Substances in schedule I are those
that have a high potential for abuse, no currently accepted medical use
in treatment in the United States, and a lack of accepted safety for
use under medical supervision. Available data and information for
furanyl fentanyl indicate that this substance has a high potential for
abuse, no currently accepted medical use in treatment in the United
States, and a lack of accepted safety for use under medical
supervision. As required by section 201(h)(4) of the CSA, 21 U.S.C.
811(h)(4), the Administrator, through a letter dated June 22, 2016,
notified the Assistant Secretary of the DEA's intention to temporarily
place this substance in schedule I.

Conclusion

This notice of intent initiates an expedited temporary scheduling
action and provides the 30-day notice pursuant to section 201(h) of the
CSA, 21 U.S.C. 811(h). In accordance with the provisions of section
201(h) of the CSA, 21 U.S.C. 811(h), the Administrator considered
available data and information, herein set forth the grounds for his
determination that it is necessary to temporarily schedule furanyl
fentanyl in schedule I of the CSA, and finds that placement of this
synthetic opioid substance into schedule I of the CSA is necessary in
order to avoid an imminent hazard to the public safety.

Because the Administrator hereby finds that it is necessary to
temporarily place furanyl fentanyl into schedule I to avoid an imminent
hazard to the public safety, any subsequent final order temporarily
scheduling this substance will be effective on the date of publication
in the Federal Register, and will be in effect for a period of two
years, with a possible extension of one additional year, pending
completion of the regular scheduling process. 21 U.S.C. 811(h)(1) and
(2). It is the intention of the Administrator to issue such a final
order as soon as possible after the expiration of 30 days from the date
of publication of this notice. Furanyl fentanyl will then be subject to
the regulatory controls and administrative, civil, and criminal
sanctions applicable to the manufacture, distribution, reverse
distribution, importation, exportation, research, conduct of
instructional activities and chemical analysis, and possession of a
schedule I controlled substance.

The CSA sets forth specific criteria for scheduling a drug or other
substance. Regular scheduling actions in accordance with 21 U.S.C.
811(a) are subject to formal rulemaking procedures done "on the record
after opportunity for a hearing" conducted pursuant to the provisions
of 5 U.S.C. 556 and 557. 21 U.S.C. 811. The regular scheduling process
of formal rulemaking affords interested parties with appropriate
process and the government with any additional relevant information
needed to make a determination. Final decisions that conclude the
regular scheduling process of formal rulemaking are subject to judicial
review. 21 U.S.C. 877. Temporary scheduling orders are not subject to
judicial review. 21 U.S.C. 811(h)(6).

Regulatory Matters

Section 201(h) of the CSA, 21 U.S.C. 811(h), provides for an
expedited temporary scheduling action where such action is necessary to
avoid an imminent hazard to the public safety. As provided in this
subsection, the Attorney General may, by order, schedule a substance in
schedule I on a temporary basis. Such an order may not be issued before
the expiration of 30 days from (1) the publication of a notice in the
Federal Register of the intention to issue such order and the grounds
upon which such order is to be issued, and (2) the date that notice of
the proposed temporary scheduling order is transmitted to the Assistant
Secretary of HHS. 21 U.S.C. 811(h)(1).

Inasmuch as section 201(h) of the CSA directs that temporary
scheduling actions be issued by order and sets forth the procedures by
which such orders are to be issued, the DEA believes that the notice
and comment requirements of section 553 of the Administrative Procedure
Act (APA), 5 U.S.C. 553, do not apply to this notice of intent. In the
alternative, even assuming that this notice of intent might be subject
to section 553 of the APA, the Administrator finds that there is good
cause to forgo the notice and comment requirements of section 553, as
any further delays in the process for issuance of temporary scheduling
orders would be impracticable and contrary to the public interest in
view of the manifest urgency to avoid an imminent hazard to the public
safety.

Although the DEA believes this notice of intent to issue a
temporary scheduling order is not subject to the notice and comment
requirements of section 553 of the APA, the DEA notes that in
accordance with 21 U.S.C. 811(h)(4), the Administrator will take into
consideration any comments submitted by the Assistant Secretary with
regard to the proposed temporary scheduling order.

Further, the DEA believes that this temporary scheduling action is
not a "rule" as defined by 5 U.S.C. 601(2), and, accordingly, is not
subject to the requirements of the Regulatory Flexibility Act (RFA).
The requirements for the preparation of an initial regulatory
flexibility analysis in 5 U.S.C. 603(a) are not applicable where, as
here, the DEA is not required by section 553 of the APA or any other
law to publish a general notice of proposed rulemaking.
Additionally, this action is not a significant regulatory action as
defined by Executive Order 12866 (Regulatory Planning and Review),
section 3(f), and, accordingly, this action has not been reviewed by
the Office of Management and Budget (OMB).

This action will not have substantial direct effects on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government. Therefore, in accordance with Executive Order
13132 (Federalism) it is determined that this action does not have
sufficient

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federalism implications to warrant the preparation of a Federalism
Assessment.